FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAR 55 MODEL 100
K Number: K090172
·
Decision Jun 5, 2009
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
411
Applicant Total
18
Review Days
133
Basic Information
- Device Name
- STAR 55 MODEL 100
- K Number
- K090172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LARSEN & TOUBRO LIMITED
- Date Received
- January 23, 2009
- Decision Date
- June 5, 2009
- Product Code
- MHX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MHX), ordered by most recent decision date.
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
FDA 510(k)
FDA Class 2
·Cardiovascular
Radius VSM and Accessories
FDA 510(k)
FDA Class 2
·Cardiovascular
Telemetry Monitor 5500 Release 4.0 (867232)
FDA 510(k)
FDA Class 2
·Cardiovascular
Infinity CentralStation Wide
FDA 510(k)
FDA Class 2
·Cardiovascular
Patient Monitor (RespArray)
FDA 510(k)
FDA Class 2
·Cardiovascular
Corvair
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by LARSEN & TOUBRO LIMITED
| K Number | Device Name | ||
|---|---|---|---|
| K103686 | STAR 50 N | Mar 15, 2011 | Substantially Equivalent |
| K103763 | STELLAR 300 | Mar 11, 2011 | Substantially Equivalent |
| K093017 | STELLAR 300 | Apr 29, 2010 | Substantially Equivalent |
| K092153 | SKYLINE 55, MODEL VER 1 | Nov 20, 2009 | Substantially Equivalent |
| K090443 | PLANET 55, MODEL 100 | Jun 5, 2009 | Substantially Equivalent |
| K082685 | GALAXY 55 | Sep 26, 2008 | Substantially Equivalent |
| K081552 | SKYLINE 55 | Jul 31, 2008 | Substantially Equivalent |
| K080173 | STAR 55 | Feb 8, 2008 | Substantially Equivalent |
| K071472 | PLANET 55 | Sep 21, 2007 | Substantially Equivalent |
| K061816 | GALAXY | Jul 12, 2006 | Substantially Equivalent |